Comparing two types of transcatheter aortic valves for patients with valve deterioration
Clinical Trial of the Results of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication
This study is testing which of two types of heart valves works better for patients who need a replacement due to valve problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 104 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundación EPIC Academic / other |
| Locations | 9 sites (L'Hospitalet de Llobregat and 8 other locations) |
| Trial ID | NCT06049654 on ClinicalTrials.gov |
What this trial studies
The VIVALL-2 study is a randomized trial designed to compare the effectiveness of the self-expandable Allegra valve and the balloon-expandable Edwards valve in patients with severely degenerated biological aortic surgical valves. A total of 104 patients will be enrolled and randomly assigned to receive one of the two valve systems during a valve-in-valve procedure. The primary outcome will be assessed through trans-thoracic echocardiography to measure the trans-aortic mean gradient at 30 days post-procedure. Secondary outcomes will include the rate of moderate or severe prosthesis mismatch at the same time point.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with severe deterioration of a biological aortic valve and related cardiac symptoms.
Not a fit: Patients who are pregnant, have a known hypersensitivity to antithrombotic therapy, or have biological aortic valve thrombosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes for patients undergoing valve-in-valve procedures for aortic valve deterioration.
How similar studies have performed: Previous studies have shown promise in the use of transcatheter aortic valves, making this approach a continuation of established methods rather than a completely novel concept.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients meeting ALL the following criteria will be included: * Patients aged ≥ 18 years. * Severe haemodynamical valve deterioration of a biological aortic valve implanted surgically, including severe valve stenosis (effective aortic valve area \< 1.0 cm2) and/or severe valve regurgitation. * The patient has cardiac symptoms and/or deterioration of left ventricular ejection fraction attributable to the aortic valve disease. * Heart team decision of VIV procedure. * Patient is willing to return at 30 days for TTE and to be clinically contacted at 1 year. Exclusion Criteria: Patients meeting, at least, 1 of the following criteria will be excluded: * Patients who openly express their refusal to participate in the study. * Female patients in gestational age. * Presence or suspicious of biological aortic valve thrombosis. * Known hypersensitivity or contraindication to antithrombotic therapy (or inability to be anticoagulated during the procedure), nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated. * Ongoing sepsis and/or suspicious or diagnosis of endocarditis. * Patients whose life expectancy is \< 1 year due to non-cardiac comorbid conditions. * Medical, social, or psychological conditions that preclude the subject from appropriate consent or adherence to the protocol required follow-up exams. * True inner diameter of the prosthetic valve \> 27 mm. * Transfemoral access inadequate to accommodate an 18F sheath. * Patients included in other clinical trials (excluding registries).
Where this trial is running
L'Hospitalet de Llobregat and 8 other locations
- Hospital Universitari de Bellvitge — L'Hospitalet de Llobregat, Spain (Recruiting)
- Hospital Clinico San Carlos — Madrid, Spain (Recruiting)
- Hospital Universitario de La Paz — Madrid, Spain (Recruiting)
- Hospital Universitario Puerta De Hierro — Majadahonda, Spain (Recruiting)
- Hospital Clínico Universitario de Salamanca — Salamanca, Spain (Recruiting)
- Hospital Universitari I Politècnic de La Fe — Valencia, Spain (Recruiting)
- Manchester University NHS Foundation Trust — Manchester, United Kingdom (Recruiting)
- Freeman Hospital — Newcastle, United Kingdom (Recruiting)
- Morriston Hospital, Swansea — Swansea, United Kingdom (Recruiting)
Study contacts
- Study coordinator: RAÚL MORENO GÓMEZ, MD, PhD
- Email: raulmorenog@hotmail.com
- Phone: 0034917277000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.